Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: Brentuximab vedotin
Trade Name: Adcetris
Date Designated: 09/07/2016
Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders
Orphan Designation Status: Designated/Approved
Seagen Inc.
21823 30th Drive Southeast
Bothell, Washington 98021
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Brentuximab vedotin
Trade Name: Adcetris
Marketing Approval Date: 11/09/2017
Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity End Date: 11/09/2024 
Exclusivity Protected Indication* :  For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-